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This is what you will do:

The QC Chemistry Manager will lead and manage all aspects of Chemistry testing in support of in-process, drug substance and drug product release and stability testing in support of the College Park manufacturing facility as well as the Global QC Centre of Excellence. The position will support maintenance of regulatory compliance through established programs for the oversight of Alexion Dublin laboratories. The role will also support the strategic efforts ongoing with regards to capacity management and lean labs.

You will be responsible for:

  • QC management and technical oversight for all internal testing in the QC Centre of Excellence (COE), Dublin, for all Alexion products manufactured internally and externally.
  • Manage the QC Chemistry team, to ensure the timely and reliable testing of in-process, release and stability testing for drug substance and drug product lots on site. This includes resource management, capacity management, lab performance management and method reliability.
  • Lead and maintain a high performing team, including QC analysts, specialists and supervisors
  • Accountable for the team operating model, org structure, people and talent strategy, succession planning, reward & recognition.
  • Ensure technical and Quality oversight of laboratory investigations and issue management as required. Represent the QC laboratories to Senior Management, customers and stakeholders as required. This includes supporting complex lab investigations as appropriate.
  • Supports QMR, responsible for QC support of the APQR process and Process Monitoring support, supporting the co-ordination and technical review of responses to agency questions on analytical methods, supporting inspection readiness for internal and regulatory inspections, training compliance, represents QC on the Change Control Review Board (CCRB)
  • Accountable to implement efficient processes, tracking. Responsible to implement and sustain Lean Lab initiatives, including performance management, right first time, standard work, visual management and tiered metrics/KPIs.
  • Personnel development, SMART objective setting and coaching completing regular One: Ones with all direct reports
  • Headcount maintenance and recruitment
  • Support critique of analytical sections/normative documents for all new filing applications for Alexion products as required

You will need to have:

  • B.A. / B.Sc. or equivalent in Biological Sciences, Chemistry or other biotechnical science or equivalent experience in regulated industry.
  • Minimum 10 years of laboratory experience in a GMP laboratory
  • Proven ability to work in a matrixed organization.
  • In depth understanding of current regulatory requirements for QC, including QC testing, data integrity, supplier management.
  • Knowledge of business and management principles involved in resource allocation
  • Experience of involvement in technical issue resolution, in a multidisciplinary environment
  • Strong organizational, conflict management and decision-making skills are required.
  • Must be able to manage multiple priorities, maintain confidentiality, and operate with poise and professionalism in a complex, high-profile, and rapidly changing environment.

We would prefer for you to have:

  • 5+ years of supervisory/ management leadership experience
  • Experience of EQV, Empower and documentation systems would be an advantage.
  • Business process mapping experience
  • Has previously demonstrated success in managing a team.
  • Project management skills.
  • Excellent written and verbal skills and strong interpersonal skills
  • High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint. 

Date Posted

07-Feb-2024

Closing Date

28-Mar-2024

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

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Confirmed 5 hours ago. Posted 30+ days ago.

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